EmbryoScope time-lapse systems. Making time-lapse a standard of care.

Transcription

1 EmbryoScope time-lapse systems Making time-lapse a standard of care. 1

2 Improve IVF treatment through better embryo selection Time-lapse technology reduces observational time restrictions and stress to embryos during culture and assessment. With time-lapse you can enjoy undisturbed culture and continous image acquisition and improve your selection process through a more objective analysis. Solving the observational dilemma The desire to observe embryos regularly in order to make accurate assessments, while minimising disturbance to avoid stressing them, has been a long-standing dilemma. Time-lapse technology solves this problem by giving you continuous observation in an undisturbed culture. Once taken, acquired images can be played as a film that can be analysed at the clinic and remotely. Without time-lapse, embryos must be taken out of the incubator to be assessed, exposing them to unnecessary stress and fluctuations. 2

3 Making time-lapse a standard of care With the introduction of time-lapse technology, the field of assisted reproduction took a leap forward. Time-lapse monitoring systems present a significant potential in improving IVF treatment on all levels. Simultaneously, time-lapse technology introduces new opportunities in the clinic for improving workflow, quality control and communication between embryologists, clinicians and patients. Most importantly, time-lapse culture and evaluation has been proven to increase clinical outcome and reduce pregnancy loss Time-lapse culture and evaluation improve IVF success Improved implantation rate Time-lapse improves your chances of transferring a viable embryo, resulting in increased clinical outcome. 1,2,3,4,6,7,10,11 Reduced pregnancy loss Selecting the most viable embryo for implantation also means reducing the percentage of pregnancies lost or aborted. 2,11 Shorter time to pregnancy Improving the clinical pregnancy rate while decreasing pregnancy losses effectively shortens the overall time to pregnancy. Improved implantation rate Reduced pregnancy loss Percent Traditional culture and evaluation n=699 p= Time-lapse culture and evaluation n=775 Rubio et al (2014) Percent p= Rubio et al. (2014) Early pregnancy loss n=228 n=271 p= Barrie et al. (2016) Miscarriage rate n=176 n=201 Improved pregnancy rate Percent p= p= Rubio et al. (2014) Ongoing pregnancy rate Goodman et al. (2015) Clinical pregnancy rate n=405 n=438 n=116 n=119 One of the immediate benefits of EmbryoScope compared to traditional incubation is better culture conditions. This was the reason behind moving towards using 100 % time-lapse in the center s laboratory Dr. Nikica Zaninovic, Embryology Laboratory Director and Assistant Professor, Weill Medical College of Cornell University, USA Traditional culture and evaluation Time-lapse culture and evaluation 3

4 undisturbed culture and time-lapse evaluation working together EmbryoScope and EmbryoScope+ time-lapse systems offer improved clinical outcomes through undisturbed stable incubation and time-lapse monitoring. The world s most used time-lapse system for IVF since The world s most used time-lapse system EmbryoScope is the most widely adopted time-lapse system worldwide with documented improved clinical outcome and neonatal follow-up. The system is developed based on input from hundreds of leading scientists and is the first time-lapse system cleared for clinical use in Europe and USA. In addition to an excellently stable incubation environment, both EmbryoScope and EmbryoScope+ time-lapse systems also provide software and decision support tools designed to provide both flexibility and consistency, improving the clinic s results and workflow. Undisturbed stable incubation EmbryoScope and EmbryoScope+ share the same state-of-the-art technology that enables a stable culture environment for embryos. Temperature is tightly regulated by direct heat contact and air is continuously purified through a HEPA/VOC filter. An integrated gas mixer allows the implementation of reduced oxygen conditions easily and economically. Small incubation chambers allow rapid recovery of culture conditions after door opening. EmbryoScope has space for 6 patients with up to 12 embryos in each EmbryoSlide culture dish whereas EmbryoScope+ can hold 15 patients with up to 16 embryos in each dish. Lower energy light exposure than traditional microscopy Scalar Irradiance (µw cm -2 nm -1 ) 1,200 1,000 0,800 0,600 0,400 0,200 Light Toxicity 0, Microscope IVF clinic Max Wavelength (nm) Microscope IVF clinic Average EmbryoScope Max Graph from Li, R., et al Ensure the best possible embryo culture environment The heart of the system is the incubator. Both EmbryoScope and EmbryoScope+ provide a stable incubation environment while high quality images of embryo development are acquired. Extensive testing has shown that light exposure in EmbryoScope systems is outside of damaging wavelenghts and with much lower total light energy exposure than traditional microscopy. 12 4

5 Constant time-lapse monitoring EmbryoScope as well as EmbryoScope+ acquire images of all embryos in multiple focal planes. Both systems use high-quality Hoffman modulation contrast optics and acquire images of each individual embryo separately. This results in supreme image quality which allows observation of key morphological features. The image acquisition has been thoroughly validated to ensure safety in terms of both light wavelength and total energy exposure. Image data handling has been carefully considered to minimise data storage requirements while maintaining optimum image quality. This ensures seamless video playback. Enjoy flexible work routines never miss a thing By integrating EmbryoScope technology in the IVF laboratory, a new world of efficiency and productivity opens up. A great deal of stress is reduced when assessment and evaluation of embryos is performed when it suits the task flow. With EmbryoScope technology, observations are not connected to fixed time-points, which both reduces the morning rush hour and frees up resources in the laboratory. Tool for communication and consistency With time-lapse information gained from EmbryoScope technology, communication is taken to a new level. Both between clinicians and embryologists, among embryologists in the lab and with patients. The level of understanding of embryo development and its dynamic process is increased, which is ideal to use when training new embryologists. Finally, time-lapse information makes standardising embryo evaluation a possibility, enhancing consistency. As the first clinic in the world to introduce time-lapse technology for all patients in 2010, we have seen an improvement in implantation rates while reducing multiple pregnancy rates by way of more single embryo transfer. We are confidently using EmbryoScope+ routinely for our patients. We have the same great results, with the added benefit of higher patient and embryo capacity as well as space savings in the lab. Medical Director John Kirk, Maigaard Fertility Clinic, Denmark Barcode label printer EmbryoScope/ EmbryoScope+ time-lapse incubator ES server Thin client to run software and barcode label printer EmbryoViewer workstation with keyboard, mouse, and scroll wheel 5

6 start big or go bigger Optimise embryo culture and evaluation and maximise your results with either EmbryoScope or EmbryoScope+, depending on your clinic s needs and wishes. EmbryoScope+, high capacity with a small footprint EmbryoScope+ is designed to meet the needs of clinics wishing to implement time-lapse as a standard of care to more of their patients. EmbryoScope+ has more than double the patient capacity, compared to other bench-top time-lapse systems. The EmbryoScope+ can simultaneously acquire time-lapse videos from up to 15 patient dishes with up to 16 embryos each making it ideal for clinics who wish to offer time-lapse to all of their patients. To improve workflow, the EmbryoSlide+ culture dishes are automatically registered using a special patient barcode labelling system. With the small footprint you will make efficient use of space, a valued asset in all labs and especially where space is limited. The large capacity in combination with a small footprint and efficient workflow provides optimised usage of clinic resources. EmbryoSlide+ 16 embryos/dish, 15 dishes/incubator Barcode labelling 2 x 8 embryos distinct loading areas 2 x 180µl medium 1.6 ml oil 4 flushing / rinsing wells Individually numbered wells NEW! ph validation dish Silicone lid 3.0mL medium Intended for ph value measurements MEA tested For single use only Supportive software Time-lapse analysis of embryo development is the key to improved evaluation. Data generated from EmbryoScope+ is analysed using the flexible EmbryoViewer software which allows viewing and analysis of embryos. 6

7 EmbryoScope, the world s most used Based on more than a decade of experience in optimal design and a specialised knowledge of all processes involved when incubating and monitoring embryos, EmbryoScope time-lapse system continues to offer safe embryo management through a platform of products and services. EmbryoSlide 12 embryos/dish, 6 dishes/incubator 12x25µl medium 4 flushing / rinsing wells Individually numbered wells Lid ensures minimal evaporation Handling fin for safe transfer between workplaces The integrated design of the EmbryoScope time-lapse incubator has been developed to ensure stable incubation while automatically acquiring images of the developing embryos at defined intervals. This information is transferred to the ES server which can then be accessed from conveniently placed EmbryoViewer stations. Easy patient addition workflow A patient identification barcode system offers a flexible and efficient workflow. EmbryoScope+ automatically reads and registers entry of a new patient and re-entry of an existing patient dish. Minimal culture disturbance The EmbryoSlide culture dish handling port is isolated from the remainder of the incubation chamber. This unique design ensures that culture conditions inside the incubator are virtually undisturbed when a patient culture dish is added or removed. Easy and efficient gas and temperature validation An easy to access gas sampling port is positioned at the front of the EmbryoScope+. An intuitive menu guides the process of setting and validating gas and temperature set points. 7

8 Powerful evaluation and selection software With time-lapse technology, images are taken continuously as an embryo develops. The resulting film sequence can reveal critical events that are often missed in the snap-shot glimpses of conventional microscopy, allowing you to make more informed decisions. EmbryoViewer software allows you to perform advanced embryo analysis to improve selection of embryos most suited for transfer and cryopreservation. Get the most information to make the best choice Traditional evaluation of embryos limits the amount of information about embryo development. Using time-lapse analysis, you can detect previously unseen embryo development patterns and events which have been correlated to clinical outcome. With EmbryoViewer software, you can analyse high quality videos of embryo development and easily enter information which facilitates side by side comparison and ranking of embryo quality. 8

9 See what you ve been missing With EmbryoViewer software, you can achieve improved selection, or de-selection, of embryos by a combination of discovering both morphological and morphokinetic parameters. Important parameters such as the dynamic morphology, critical cleavage patterns and morphokinetics can only be observed with time-lapse technology. Traditional embryo assessment has been reported to miss more than 70% of embryo multinucleation while more than 20% of embryos have been reported to go through an abnormal cleavage pattern. Such patterns can only be precisely determined by the use of time-lapse Standard evaluation misses up to 72.4% of multinucleated embryos Up to 26% of embryos go through an abnormal cleavage pattern Effect of multinucleation Percent MN p= Clinical pregnancy Implantation n=145 n=366 n=159 n=527 No MN p=0.001 Transferred embryos retrospectively checked for multinucleation (MN) at 2-cell stage by time-lapse images. Only 27.6% of multinucleated embryos were identified within traditional time limits for embryo assessment (n=159). Multi nucleation significantly reduced clinical pregnancy rate and implantation rate. Ensure consistency with annotations Registering embryo traits with the specific time of occurrence enables the transition from analogue assessment to assessment by digital information. For embryo evaluation, digital information has the advantage of being more precise and less risk of subjectivity. This sets the basis for consistent evaluation. Ergin, E.G. et al (2014) Time-lapse expands your evaluation capabilities NORMAL 2-CELL 3 4-CELL CELL M BLAS ABNORMAL 2-CELL CELL MORULA BLAS VISIBLE NUCLEI Standard observation misses visible nuclei; time-lapse records everything. Normal and abnormal cleavage (2 to 5 cells and 1 to 3 cells). Morphokinetics reflect the exact timing of embryo developmental events and have been used to distinguish between normal and abnormal development Observe changes in morphology in near real-time Identify abnormal cleavage patterns as they occur Monitor morphokinetics 9

10 Advanced software With EmbryoViewer software, you can review, annotate and compare development of selected embryos from data acquired by the EmbryoScope and EmbryoScope+. The same EmbryoViewer software can be used for both types of incubators. The incubators running conditions are automatically stored with the patient data and can be observed on the EmbryoViewer software for quality assurance. Intuitive annotation tools With EmbryoViewer software, you can annotate cell division events, providing an easy overview of observations in developmental stages. High quality Hoffman modulation contrast images which allows observation of key morphological events Selection of different focal planes to observe details of interest Automatically calculated cellular activity indicating cell division events (patented) 47.6h Elapsed time from insemination Tools to indicate which embryos to transfer, cryopreserve or avoid All annotations and notes are saved for future reference 10

11 Improved basis for embryo selection View and compare all of patient s embryos from an EmbryoSlide culture dish at the same time. Select a single embryo for annotation or use View slide to perform a side-by-side comparison of all embryos in a culture dish. Assisted embryo selection With EmbryoViewer software, you also have the possibility to set up one or more models according to clinic specific criteria and rank embryos accordingly using the Compare & Select feature. With the possibility to define selection, deselection or information criteria and even user defined variables, you can create customised models with criteria fitting your own clinical data. Improved workflow with ES server When introducing EmbryoScope and/or EmbryoScope+ to your IVF laboratory, you are guaranteed a digital transformation in the workflow. With the ES server, you can access the time-lapse data from all connected EmbryoScope and EmbryoScope+ incubators. Moreover, it is possible to view the data from multiple EmbryoViewer workstations. These can be placed in the IVF laboratory or in your office, and you can even access the data stored on the server from another clinic or another remote location using a secure connection. This enables you and your colleagues to view, annotate and select embryos with geographical flexibility. NEW! Electronic Medical Record integration EmbryoScope can be integrated with all compatible EMR systems. Use View slide to see all embryos from one dish at the same time ES server connects all equipment and software in the clinic as well as on remote locations LABORATORY EmbryoScope incubators EmbryoViewer workstations ES server The Compare and select feature lets you apply a predefined model to rank embryos DOCTOR S OFFICE EmbryoScope counseling app REMOTE LOCATION EmbryoViewer software 11

12 add intelligence with guided annotation Guided Annotation is an added, optional tool in the EmbryoViewer software designed to provide a simplified annotation workflow. The intelligent annotation system jumps to likely division timings based on our unique blastomere activity measurements you simply confirm the event with the press of a button. Ensure consistent evaluation of embryos with Guided Annotation The EmbryoViewer software allows you to observe each embryo through every stage of development from data acquired by the EmbryoScope time-lapse system. It is here this information is annotated in order for you to evaluate which embryos are most suitable for transfer and/or freezing. The software s proprietary blastomere activity chart has been utilised to rapidly identify cell division events in order to simplify annotation. This chart is calculated for each embryo using an advanced image analysis program. The Guided Annotation tool uses this image analysis to guide you to likely timings for developmental events like division timings, morphology assessment and PN check. Simply validate or score the event by a single keyboard click. Eased workflow, efficiency and consistency Simplicity Based on the annotation strategy, Guided Annotation automatically prompts you to annotate the selected variables. A continuous overview of the process is provided. Efficiency An efficient workflow is easily achieved by utilising customised annotation strategies in combination with the intuitive and ergonomics friendly keyboard shortcuts. Consistency Define an annotation strategy, or determine which predefined annotation strategy to use, and collect consistent and valuable information by all staff. Blastomere activity chart Guided Annotation in synergy with KIDScore optimally supports your consistent embryo evaluation process 12

13 Follow an annotation strategy At the core of the tool lies a user defined annotation strategy. It indicates which variables you should annotate and in which order. Once a strategy has been defined, the tool guides you through the process of performing the actual annotations: 1. All variables included in the selected annotation strategy are automatically presented to you together with an image of the current embryo. 2. The image series is automatically forwarded to an estimated point in time where the annotation process may start. 3. You complete the step by evaluating the embryo and performing the actual annotation. The Annotate Page displays an image of the selected embryo, placed above the division and blastomere activity chart Buttons and short-cut indications for performing annotations Current annotation strategy and values List of identified embryos with associated decisions and annotation progress Strategy drop-down Continuous overview of annotation progress Apply a selection model and view scoring side by side. Comments and custom annotations are also visible to aid in final decisions 13

14 KIDScore decision support tool KIDScore assigns an objective score to each embryo. The scores reflect implantation potential and provide consistent and effective support for embryo selection. KIDScore for transfer on Day 3 or Day 5 The KIDScore decision support tool is developed by analysing the world s largest database of embryo development with known clinical outcome. The models are developed by analysing how embryo morphokinetics, cleavage patterns and morphology correlates with implantation outcome after transfer. Principles of KIDScore D3 Implantation Enjoy immediate benefits of time-lapse-based embryo analysis Improved consistency of evaluation and lower interobserver variability 17 Uses easy-to-annotate variables Based on Known Implantation Data (KID) from the day of transfer A powerful tool when you have more embryos available than planned for transfer Designed to predict implantation Range of a morphokinetic variable Time Low implantation Benefits of KIDScore Improves the decisionmaking process Enhances consistency Helps you obtain better results t4 t5 t6 t3 t7 t2 t8 tpnf 2PN Embryo development Data analysis Outcome KIDScore 14

15 KIDScore D3 When to use it When deciding between embryos that reach expected stage on day 3 When D3 SET is preferred How does it work? KIDScore D3 assigns a morphokinetic score from 1-5 to your annotated embryos. The score from 1-5 is a relative measure of the implantation potential of the embryo. The following variables need to be annotated in accordance with specific guidelines: PN assessment, PN fading, time (t) to 2, 3, 4, 5 and 8 cells. KIDScore D3 & implantation data The chart represents unselected embryos, embryos chosen for transfer, implanted embryos and embryos resulting in a live birth from cycles where known outcome data is available. The distribution of embryos across score groups is shown. This indicates that there is excellent concordance between the model and embryos with high implantation potential. KIDScore D5 When to use it When more good quality blastocysts are available than are planned for transfer When deciding which embryos are suitable for biopsy or diagnosis How does it work? KIDScore D5* considers the morphology and the morphokinetic traits of an embryo. For each embryo the model calculates a continuous score from The score reflects the statistical chance of implantation based on development information from the five-day culture period. The higher the score, the greater the statistical chance of implantation. Only a few annotations are required to obtain a score, which further improves the worfklow. KIDScore D5 & implantation data KIDScore D5 scores show an increased relative implantation with higher scores. The model is based on a large database of KID blastocysts originating from a wide range of IVF clinics. *KIDScore D5 can only be used when culturing under reduced oxygen conditions KIDScore D3 correlates with higher implantation potential KIDScore D5 correlates with increased implantation Distribution (%) All embryos (n~11,000) Transferred (n~3,300) Implanted (n~800) Liveborn (n~250) KID positive (%) Score groups KIDScore D5 score 15

16 Improve your patient communication Inform patients about their IVF treatment and development of their embryos with the EmbryoScope Counseling App. Time-lapse embryo development videos support your communication Not only does time-lapse increase communication between clinical staff, it also advances patient communication. Embryo development videos can be used to show patients why a cycle may have failed when only poor quality embryos are available. They can also show patients who have many good quality embryos that single embryo transfer is a good option. Or they can give them hope that their good quality frozen embryos may offer them a second chance. 18 The EmbryoScope Counseling App offers the capability of educating your patients about embryo development. Moreover, the app offers the ability to show patients the videos of how their own embryos developed in both the EmbryoScope and the EmbryoScope+ time-lapse incubators. Educate and interact with your patients with EmbryoScope Counseling app An ideal tool for patient consultation Guide patients through the EmbryoScope time-lapse system treatment benefits versus traditional incubation Show examples of good and poor developing embryos Log in to show patients how their own embryos have developed Find the EmbryoScope Counseling App on the App Store on your ipad and get free access to the app s main features. The capability of showing patients their own embryos requires an annual ES server connection license for each device used. 16

17 Extensive training and support Get the most from your investment. With extensive experience from IVF labs around the world we can provide you with extensive support and training, to get you started and help you utilise time-lapse to its fullest potential. Installation by a certified instructor When you have invested in an EmbryoScope time-lapse system, a certified instructor from Vitrolife will install the system in your clinic. During the installation, we provide a thorough, interactive demonstration of the system and education in using its functions with the focus of training you to use it to its full potential. 24-hour support Half-yearly service visits ensure the continuous, optimal performance of all instrument components. Also, a 24-hour technical support is at your disposal via our customer hotline, which responds to all issues relating to your EmbryoScope time-lapse system. Both the half-yearly service visits and access to the 24-hour technical support require a maintenance agreement. Online scientific support You also have the possibility to advance your time-lapse use with Vitrolife s online scientific support for time-lapse application. Online scientific support focuses on your practical use of time-lapse technology in all parts of your clinic s workflow and on the scientific basis that this builds on. An online session will be designed to target the issues relevant to your needs and can include information sharing, demonstrations and questions & answers. Each online session is set up for your individual clinic. 17

18 EmbryoScope time-lapse incubator EmbryoScope+ time-lapse incubator Instrument Capacity Operation Six (6) disposable EmbryoSlide culture dishes holding 12 embryos each Individual culture dishes may be inserted and removed independently Fifteen (15) disposable EmbryoSlide+ culture dishes holding 16 embryos each Individual culture dishes may be inserted and removed independently Patient data Entered manually Read automatically from barcode Dimensions W x D x H (60.3 x 56.0 x 43.5) cm / (23.7 x 22 x 17.2) in W x D x H (55 x 60 x 50) cm / (21.7 x 23.6 x 19.7) in Weight 60 kg / 121 lbs 50 kg / 110 lbs Input voltage Versions compatible with different regional voltages available Versions compatible with different regional voltages available Power consumption Max 250 W, typical 95W Max 250 W, typical 95 W Operating range 20 C 30 C 20 C 28 C Alarm system Monitoring of incubation conditions and subcomponent integrity; audible and visible alerts when incubation conditions are out of range. Monitoring of incubation conditions and subcomponent integrity; audible and visible alerts when incubation conditions are out of range. Image acquisition Focal planes Built-in microscope Camera resolution Embryo illumination Time between acquisitions Up to seventeen (17) focal points at each time point Leica 20x, NA 0.40 LWD Hoffman modulation contrast objective lens pixels, 3 pixels per μm, monochrome, 8-bit 0.032s per image using single red LED (635nm) gives 43 J m -2 for image acquisition (5 day culture) 10 min. cycle time for 7 focal planes, 2 min cycle time with single focal plane Eleven (11) focal points at each time point Custom designed 16x, NA 0.50, LWD Hoffman modulation contrast objective lens 2.2 MP, 3 pixels per µm, monochrome, 12-bit 0.020s per image using single red LED (630nm) gives 42 J m -2 for image acquisition (5 day culture) 10 min. cycle time for 11 focal planes Tri-gas incubator, integrated in instrument Temperature 30 C to 45 C ± 0.2 C* * Temperature range: Temperature set-point must be at least 7 C above ambient temperature and ambient temperature must be less than 30 C. 36 C to 39 C ± 0.2 C Oxygen 5 % to 20 % ± 0.3 % 4 % to 8 % ± 0.5 % or ambient N 2 consumption At 5 % O 2 : <20L/h Max 5 L/hr, typical 2-3 L/hr CO 2 2 % to 10 % ± 0.2 % 3 % to 8 % ± 0.3 % CO 2 consumption At 5 % CO 2 : <1 L/h (without reduced 0 2. With reduced O 2 consumption at 5 % is <2 L/h) Max 2 L/hr, typical 0.5 L/hr Active air circulation Full purification of gas volume every 20 minutes Full purification of gas volume every 6 minutes Volatile organic compounds Removed by active carbon filter Particles Removed by HEPA filter which retains % particles >0.3 μm Data acquisition, Intel based fanless embedded PC Network 100 Mb Ethernet 1 Gb Ethernet Removed by active carbon filter Removed by HEPA filter which retains 99.97% particles >0.3 µm Operating system Microsoft Windows Microsoft Windows Embedded Data format for images JPEG JPEG Monitor 12.1 embedded touch screen 10.1 capacitive touch screen Europe: CE-marked class IIa medical device. USA: FDA 510(k) clearance. Europe: CE-marked class IIa medical device. This product has not received 510(k) clearance. 18

19 EmbryoSlide culture dish* Micro well culture Microscopy Size Packaging Sterilisation method Toxicity test Labelling Twelve (12) numbered wells for incubation of individual embryos in droplets with 25 μl medium. Four (4) wells for flushing of embryos. No need for humidified environment. Fully compatible with standard and inverted microscopes Standard dish format (25 75 mm) Dishes packed individually with lid in sterile pouche. 2D barcode for batch specification. E-beam sterilised according to ISO with SAL Single use, sterile. Embryotoxicity tested with 1-cell mouse embryos minimum 80% expanded blastocysts after 96 hrs. Cytotoxicity test according to ISO Non-pyrogenic. Barcode labels not supported Europe: CE-marked class IIa medical device. USA: FDA 510(k) clearance. EmbryoSlide+ culture dish* Micro well culture Microscopy Size Packaging Sterilisation method Toxicity test Labelling Sixteen (16) numbered wells for incubation of individual embryos in reservoirs of 2 x 180µl medium. Four (4) wells for flushing of embryos. No need for humidified environment. Fully compatible with standard and inverted microscopes Dish size (50 70 mm) Europe: CE-marked class IIa medical device. This product has not received 510(k) clearance. Dishes packed individually with lid in sterile pouche. 2D barcode for batch specification. E-beam sterilised according to ISO with SAL Single use, sterile. Embryotoxicity tested with 1-cell mouse embryos minimum 80% expanded blastocysts after 96 hrs. Cytotoxicity test according to ISO Non-pyrogenic. MEA tested barcode labels for automatic patient registration. EmbryoViewer software PC Powerful small form factor PC Dimensions W x D x H (3.5 x 18.0 x 18.0) cm / (1.4 x 7.1 x 7.1) in Display dimensions Weight Input voltage Jog wheel Data export Image export format Video export format W x D x H (58.0 x 21.0 x 42.0) cm / (22.8 x 8.3 x 16.5) in 1.3 kg / 2.8 lbs V AC Delivered with for ease of video replay Patient and annotation data can be exported to Excel format for further data processing JPEG AVI Europe: CE-marked class I medical device. USA: FDA 510(k) clearance. ES server Dimensions W x D x H (17.5 x x 36.82) cm / (6.9 x 18.7 x 14.5) in Weight Input voltage Capacity kg / lbs AC 120/230 V (50/60 Hz) Europe: CE-marked class I medical device. Typically 2500 treaments (upgradable). Depends on image aquisition settings. * Design protected 19

20 Time-lapse by Vitrolife everything you need Vitrolife has everything your clinic needs to maximise time-lapse culture and evaluation, including time-lapse monitoring systems and a specially formulated culture medium. Whether you want to start with an integrated time-lapse system, complement your current set-up or start with a modular solution like Primo Vision EVO+, you can feel confident partnering with us. Optimise all the way Optimised for time-lapse technology, G-TL provides optimal culture conditions, maximising embryo viability. Time-lapse technology has allowed IVF professionals to minimise handling stress. In order to take this concept to the next level, a culture media has been developed specifically to support fully undisturbed embryo culture conditions. G-TL was the first single step culture medium specifically designed and validated to support human embryo culture in a time-lapse environment. In addition, OVOIL provides the perfect overlay to prevent evaporation. The high quality makes it ideal for the challenges presented by extended culture conditions. Orders & customer support Ordering Global tech support order.fertility@vitrolife.com support.embryoscope@vitrolife.com (24-hour hotline outside US) (US support) Vitrolife A/S. Jens Juuls Vej Viby J. Denmark. Tel Fax fertility@vitrolife.com. REFERENCES 1. Aguilar, J. et al., (2014), Reprod Biomed Online 28(4): Barrie, A. et al., (2016), Hum Fertil (Camb): Campbell, A. et al., (2013), Reprod Biomed Online 27(2): Basile, N., et al., (2015), Hum Reprod 30(2): Azzarello, A. et al., (2012), Hum Reprod 27(9): Chamayou, S. et al., (2013), J Assist Reprod Genet 30(5): Dal Canto, M. et al., (2012), Reprod Biomed Online 25(5): Desai, N., et al., (2014), Reprod Biol Endocrinol 12: Goodman, L.R. et al., (2016), Fertil Steril 105(2): e Meseguer, M. et al., (2012) Fertil Steril 98(6): e Rubio, I. et al., (2014), Fertil Steril 102(5): e Li, R., et al., (2014), J Assist Reprod Genet 31(7): Ergin, E.G. et al., (2014), Fertil Steril 102(4): e Data on file. 15. Rubio, I. et al., (2012), Fertil Steril 98(6): Zhan, Q. et al., (2016) PLoS One 11(12): e Sundvall, et al., (2013), Hum Reprod 28(12): Blomquis AB. et al., (2016), Gynecol Gest Surr - UK 1(1):1-6. This brochure contains information regarding various tests and clinical trials relating to Vitrolife products. This information on tests and clinical trials relating to Vitrolife products is only a summary provided for information purposes about Vitrolife products. The information is provided as is without any warranties, expressed or implied, including but not limited to the implied warranties of suitability or eligibility for a particular purpose and/or success of treatment on an individual basis. Products and information may have changed since the printing of this brochure. For more information see Vitrolife REF 19109